Global Clinical Program Lead
About The Position
At Roche, we foster a culture where individuals can express themselves authentically, are embraced for their unique qualities, and where personal expression, open dialogue, and genuine connections are encouraged. We value, accept, and respect everyone, enabling them to thrive personally and professionally. Our mission is to prevent, stop, and cure diseases, ensuring universal access to healthcare for present and future generations. Join Roche, where every voice matters. A healthier future is our driving force for innovation. We continuously advance science to ensure everyone has access to the healthcare they need today and for generations to come. Our goal is to create a world where we all have more time with the people we love. That's what makes us Roche. As a Clinical Program Lead within the Clinical Development and Medical Affairs (CDMA) chapter, you will provide high-level strategic leadership and scientific rigor for global evidence generation programs. You will act as the primary strategic architect between Life Cycle Teams (LCT) and clinical execution, ensuring diagnostic solutions are backed by robust data to improve patient outcomes. Operating in a matrixed global environment, you will drive the development of Integrated Evidence Generation Plans (IEGP) and oversee complex clinical trials from inception through regulatory success.
Requirements
- Bachelor’s degree in a scientific discipline or related field (Advanced degree preferred).
- 8+ years of project or clinical trial coordination/management experience within a regulated CRO, diagnostic, or pharmaceutical environment.
- Proven track record managing clinical trial execution, bio-sample testing/management, and quality assurance processes under strict timelines.
- Demonstrated ability to lead by influence and drive consensus within a heavily matrixed, multi-site global organization.
- Deep mastery of international regulatory standards (ICH-GCP, ISO, GMP, GLP) and diagnostic/medical testing environments (FDA, CAP, CLIA, WHO).
Nice To Haves
- Advanced degree (Master’s, Ph.D., or PharmD) in a life sciences or clinical research discipline.
- Project Management Professional (PMP) or equivalent project management certification.
- Prior experience managing clinical programs bridging IVD (In Vitro Diagnostics) or companion diagnostics with therapeutic development.
Responsibilities
- Drive the planning, development, and delivery of global evidence generation programs, maintaining full accountability for program progress, budgets, timelines, and strategic risk management.
- Architect and lead the development of Integrated Evidence Generation Plans (IEGP) for assigned products in close partnership with internal and external stakeholders.
- Serve as a strategic partner and primary interface between CDMA and Life Cycle Teams (LCTs), aligning clinical evidence generation with broader business strategies.
- Partner with Functional Partners and Sub-Chapter Leads to define resource requirements and coordinate capacity across CDMA Networks and Project Teams.
- Oversee program-level budgets and trial timelines, performing proactive scenario assessments to mitigate operational and regulatory risks.
- Ensure proactive alignment across Regulatory Affairs, R&D, Diagnostics Partners, and cross-functional CDMA chapters to ensure seamless trial execution.
- Champion a patient- and customer-centric mindset while fostering an inclusive, collaborative environment across global matrixed teams.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
